MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-08-12 for ADVIA 120 * manufactured by Bayer Diagnostics Mfg Ltd.
[421521]
In 2005 a lab manager at a medical center reported that their laboratory had sent out a discrepant result for a patient's hematocrit level that led to the patient being transfused with one unit of blood. The patient was undergoing joint replacement surgery and was being monitored for blood loss. The medical center claims that in 2005 a hematocrit test was run on the advia 120 instrument, the initial result for hematocrit of 24. 4 was reported and based on this result the patient received a blood transfusion. A subsequent test of the same sample gave a result of 27. 1%. A bayer field service engineer was dispatched to inspect the instrument. Upon inspection the engineer noted that the sample line under the needle base was loose. This causes air to be aspirated into the line, diluting the sample producing aberrant results. The engineer tightened the line and the instrument performed as intended after that.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2005-00013 |
| MDR Report Key | 627161 |
| Report Source | 05,06 |
| Date Received | 2005-08-12 |
| Date of Report | 2005-07-13 |
| Date of Event | 2005-07-08 |
| Date Mfgr Received | 2005-07-13 |
| Date Added to Maude | 2005-08-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ANDRES HOLLE |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145843494 |
| Manufacturer G1 | BAYER DIAGNOSTIC MFG. LTD |
| Manufacturer Street | * |
| Manufacturer City | DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 120 |
| Generic Name | HEMATOLOGY SYSTEM |
| Product Code | GLK |
| Date Received | 2005-08-12 |
| Model Number | ADVIA 120 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 616787 |
| Manufacturer | BAYER DIAGNOSTICS MFG LTD |
| Manufacturer Address | CHAPEL LANE SWORDS CO., DUBLIN EI |
| Baseline Brand Name | ADVIA 120 |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K971998 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-08-12 |